BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA (DDQP+)

    MDR report key: 6061473 · Received October 27, 2016

    Report

    Report Number
    2938836-2016-13366
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    August 27, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    T WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH ON DEATH CERTIFICATE NOTES CONGESTIVE HEART FAILURE. THE MANNER OF DEATH WAS NATURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711571 QUADRA ASSURA (DDQP+) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3265-40Q 3698728

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death (B)(4)| (B)(4)| (B)(4)